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WO2001032249A1 - Tracheotrode et systeme d'electroventilation tracheale - Google Patents

Tracheotrode et systeme d'electroventilation tracheale Download PDF

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Publication number
WO2001032249A1
WO2001032249A1 PCT/US2000/041748 US0041748W WO0132249A1 WO 2001032249 A1 WO2001032249 A1 WO 2001032249A1 US 0041748 W US0041748 W US 0041748W WO 0132249 A1 WO0132249 A1 WO 0132249A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrodes
tube
tracheal
electrode
cuff
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2000/041748
Other languages
English (en)
Inventor
Leslie A. Geddes
Zachary W. Sopcak
Matthew Waninger
Kirk S. Foster
William E. Schoenlein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Purdue Research Foundation
Original Assignee
Purdue Research Foundation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Purdue Research Foundation filed Critical Purdue Research Foundation
Priority to AU26214/01A priority Critical patent/AU2621401A/en
Publication of WO2001032249A1 publication Critical patent/WO2001032249A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/08—Other bio-electrical signals

Definitions

  • This invention relates to electroventilation, which is the technique of producing inspiration by stimuli applied to inspiratory muscles, directly or though associated nerves, through strategically placed electrodes on or within the body. More particularly, this invention relates to tracheal electroventilation.
  • inspiration can be produced electrically.
  • Electrical stimulation of inspiratory nerves and/or muscles provides significant advantages over commonly used ventilators, which force air into a patient's lungs through the nose and/or mouth, intermittently creating a positive intrathoracic pressure in the process.
  • Positive intrathoracic pressure reduced blood flow back to the left heart from the lungs, and thereby decreases cardiac output.
  • electroventilation produces inspiration by negative intrathoracic pressure and therefore uses the same mechanism as natural breathing.
  • the method is sometimes called diaphragm pacing, and it is useful in many situations where respiratory support is needed.
  • the electrodes are located so that the stimuli are delivered to the appropriate motor nerves.
  • Various electrode sites have been employed, such as at the base of the neck, the anterior axillary and paraxiphoid sites, the seventh intercostal space along the nipple line, over the xiphoid process, and transchest sites.
  • Percutaneous and jugular-vein electrodes have also been used in efforts to obtain better access to the phrenic nerves, which innervate the diaphragm.
  • intracaval electrophrenic stimulation involves advancing a bipolar catheter electrode into a jugular vein and applying stimuli that pass through the wall of the vein and reach a phrenic nerve.
  • Another method uses needle electrodes inserted at the cervical motor point.
  • pulsed magnetic fields have been generated with coils placed on or around the neck or on the chest, inducing eddy currents in living tissue to achieve stimulation without the use of conventional conductive skin-surface electrodes.
  • Such methods are described in a paper by L.A. Geddes entitled "Electroventilation - A Missed Opportunity?" and published in the July/ August 1998 issue of Biomedical Instrumentation & Technology.
  • the electrodes in the Hewson patent are located in the esophagus beyond the level of the tracheal carina, the ridge at the junction of the main bronchi.
  • the paper by Cochrane et al. indicates placement of an electrode at the gastroesophageal junction and in the stomach, with displacement of the electrode in 2-cm stages in an investigation of esophageal electrode position.
  • the esophageal electrode was used in conjunction with electrodes on the chest.
  • U.S. Patent No. 5,125,406 to Goldstone et al. describes an electrode endotracheal tube for detecting electromyographic signals in the laryngeal muscles.
  • a pair of electrodes running parallel to the tube axis is provided on the surface of the tube on the proximal side of an inflation cuff, so as to contact the laryngeal muscles when the tube is properly positioned in the trachea.
  • the endotracheal tube is also used for ventilating the lungs during surgery, but its ventilation function does not employ the electrodes and instead is performed in a conventional manner using a respirating machine to supply air through a main ventilation lumen.
  • the patent teaches that a circumferential electrode configuration could not be used on an endotracheal tube employed for ventilation during surgery.
  • the present invention provides a tracheotrode and a tracheal electroventilation system and method.
  • tracheotrode is a coined term intended to mean a tracheal electrode, preferably in the form of an electrode-bearing tracheal tube.
  • a tracheal electroventilation system comprises a tube sized for insertion in a trachea, the tube having proximal and distal ends and first and second surface electrodes at the distal end, and an electroventilator having first and second outputs connected respectively to the first and second electrodes and operative to supply an electrical pulse train to the electrodes to stimulate inspiration.
  • a tracheal electroventilation system comprises a pair of electrodes adapted to contact an internal tracheal surface, and means for supporting the electrodes in axially spaced relation within a trachea and in contact with an internal tracheal surface at a depth at which one of the electrodes is adjacent to the tracheal carina.
  • the system further comprises an electroventilator having first and second outputs connected, respectively, to the first and second electrodes and operative to supply an electrical pulse train to the electrodes to stimulate inspiration.
  • a method of tracheal electroventilation comprises inserting an electrode into the trachea of a patient to a depth at which the electrode is adjacent to the tracheal carina, connecting a second electrode to the patient, either internally or externally, and supplying an electrical pulse train to the electrodes to stimulate inspiration.
  • a tracheotrode comprises a tracheal tube having proximal and distal ends and an inflation cuff on the distal end, and a bipolar electrode configuration on a surface of the tracheal tube, including a first electrode proximal to the inflation cuff and a second electrode distal to the inflation cuff.
  • a tracheotrode according to yet another aspect of the invention comprises an elongated flexible member adapted for placement in the trachea of a patient without obstructing the airway, and a conductive inflatable member on the elongated Hcxiblc member.
  • Another object of the invention is to provide effective systems, methods and devices for tracheal electroventilation.
  • FIG. 1 is a side view of a tracheotrode according to one embodiment of the present invention.
  • FIG. 2 shows a tracheal electroventilation system according to one embodiment of the present invention, along with a corresponding graph of test data.
  • FIG. 3 is a side view of a tracheotrode according to another embodiment of the present invention.
  • FIG. 4 shows a tracheal electroventilation system according to another embodiment of the present invention, along with a corresponding graph of test data.
  • FIG. 5 illustrates a record of data obtained from a dog with a tracheal electroventilation system according to the present invention.
  • FIG. 1 A first embodiment of a tracheotrode 10 according to the present invention is shown in FIG. 1, wherein it can be seen that the tracheotrode comprises a tracheal tube 12 having a proximal end 14 and a distal end 16, and an inflation cuff 18 on the distal end approximately 3 cm from the tip 20 of the distal end.
  • the tracheotrode has an electrode 22 distal to the inflation cuff.
  • the electrode may be a ring electrode formed on the exterior surface of the tube with small gage bus wire, e.g., 22 gage solid tinned copper, wrapped around the tube circumference over an axial span of about 1 cm. The electrode is thus approximately 2 cm from tip 20 in the disclosed embodiment.
  • the outer diameter of the tube is approximately 15 mm, although it varies with the size of the patient.
  • the tube is in other respects a conventional tracheal tube, including an inflation port 24 and associated conduit extending through a pilot balloon 26 to cuff 18 in a known manner.
  • the tracheal tube may be uncuffed in certain applications.
  • the tube is suitably of a length adequate to reach the tracheal carina and leave only a small portion of the proximal end out of the patient's mouth in order to minimize dead space in the tube.
  • an electrode may be formed on an inflatable cuff or balloon made of conductive material, e.g., a conductive elastomer such as rubber or silastic.
  • the conductive cuff may be partially or entirely conductive, and in the former case may have multiple electrodes formed thereon, e.g., one electrode on the proximal end of the cuff and one electrode on the distal end.
  • two conductive cuffs axially spaced from each other on a tube may serve as electrodes in a bipolar configuration, described below.
  • a single cuff electrode is useful with a chest electrode in a monopolar system, as will now be described.
  • the tracheotrode of FIG. 1 is useful in a monopolar tracheal electroventilation system according to the present invention. More specifically, as shown in FIG. 2, electrode 22 is connected to a wire 28 that extends through the lumen in tube 12 (or within the tube wall) to and out of the proximal end 14 thereof, and the connecting wire is in turn connected to an output of an electroventilator 30, abbreviated as "EV" in FIG. 2. Electrode 22 serves as the cathode, while a chest electrode 32 is connected by a corresponding wire 34 to an output of the electroventilator (EV) and serves as the anode.
  • EV electroventilator
  • the chest electrode is suitably a metal disk electrode a few centimeters in diameter and may be placed over the suprastemal notch, or elsewhere on the chest.
  • the electroventilator includes a pulse generator designed to generate trains of pulses of predetermined duration at a predetermined pulse rate via an isolated output. For example, the pulse generator may generate 10- ⁇ sec pulses at a rate of 25 pulses per second to the electrodes. A short pulse duration minimizes the risk of producing cardiac arrhythmia.
  • the duration of the train which determines the duration of inspiration, may be 1 second, or longer, and the train rate, i.e., the desired breathing rate, may be a selected rate in the range of 10-30 pulse trains or inspirations per minute.
  • the train rate is desirably set slightly higher than the spontaneous respiration rate in order to capture breathing.
  • the current level is suitably increased exponentially, with an exponential rise time constant of 200 msec, up to the maximum current level.
  • a tracheotrode 40 comprises a bipolar electrode configuration on the surface of a tracheal tube 42, with a first electrode 51 just proximal to an inflation cuff 48 on the distal end 46 of the tube and a second electrode 52 just distal to the inflation cuff.
  • Both electrodes may be ring electrodes identical in construction to electrode 22 described above with reference to FIG. 1, and, as illustrated schematically in FIG. 4, they are connected by separate wires to respective outputs of an electroventilator 60, which may be identical to electroventilator 30 described above.
  • the connecting wires are preferably both internal to the tube, e.g., within the tube wall, and extend out of the proximal end 44 thereof.
  • Tracheotrode 30 may otherwise be identical to monopolar tracheotrode 10.
  • Electrodes 51 and 52 may serve as the anode and cathode, respectively, in the tracheal electroventilation system.
  • the tracheotrodes described above were tested in dogs to determine the efficacy of such electrode configurations for electroventilation. Seven dogs ranging in weight from were used as test subjects. Each animal was anesthetized with 30 mg/kg pentobarbital, intubated and placed in dorsal recumbency on a V-shaped board. Spontaneous respiration was monitored by observation of the chest and use of a capnometer (Model 47210A, Hewlett-Packard, Waltham, MA). Blood pressure was recorded with a fluid-filled catheter placed in a femoral artery and connected to a Cobe pressure transducer (Cobe Laboratories, Lakewood, CO).
  • FIG. 5 illustrates a typical record of the ECG, blood pressure, respiration, and the stimulus train envelope. The first spontaneous breath stimulation is indicated in the drawing. It can be appreciated from the record that the volume inspired increases with increasing stimulating current (indicated in mA for each stimulus train).
  • FIG. 2 is the volume versus intensity curve for the seven dogs (showing mean ⁇ standard deviation (SD)) using the monopolar tracheal electrode.
  • SD standard deviation
  • the mean spontaneous tidal volume of 252 ⁇ 80 mL is identified by the symbol " ⁇ " on the ordinate axis.
  • Volume inspired increased, as shown in FIG. 2, approximately linearly from 200 to 400 mA at a rate of 1.25 mL/mA. Above 400 mA, the volume inspired slowly plateaus with increasing current, reaching a maximum of approximately 200 mL of air for a 600 mA stimulating current.
  • FIG. 4 shows the inspired volume versus current for the bipolar tracheal electrode. From 200 to 300 mA, increasing current had little effect on inspired volume. Between 300 and 550 mA, inspired volume increases approximately linearly with current, at a rate of approximately 150 mL/mA. inspired volume reached a plateau above 550 mA. A maximum inspired volume of approximately 450 mL was reached at 600 mA. Inspired volumes greater than a single spontaneous tidal volume (252 mL) were attainable above 400 mA.
  • the monopolar and bipolar tracheal electrodes are effective to varying degrees in stimulating inspiration.
  • One advantage of the bipolar electrode is that it produces less peripheral muscle contraction than the monopolar electrode.
  • a single electrode or multiple electrodes adapted to contact an internal tracheal surface may be supported within the trachea on an elongated flexible member other than a tube.
  • a flexible member may have a partially conductive head on the end of a thin semi-rigid shaft, the head designed to maintain contact with the internal surface of the trachea without obstructing the airway.
  • the electrodes may be partial ring electrodes, e.g., semicircular in cross-section, and, in addition to being axially spaced from each other, may be located on the same side or opposite sides of the axis. Also, the ring electrodes may be solid rings rather than wound wire in certain applications.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention concerne une trachéotrode (40) destinée à l'électroventilation comprenant un tube trachéal (42) possédant un ballonnet pneumatique (48) sur sa partie distale (46) et un agencement d'électrode bipolaire le long d'une surface de ce tube comprenant une première électrode (51) proximale par rapport au ballonnet pneumatique et une seconde électrode (52) distale par rapport à ce même ballonnet. Cette invention concerne aussi un système et un procédé d'électroventilation dans lesquels un train d'impulsions électrique est délivré aux électrodes de façon à stimuler l'inspiration. Un tube endotrachéal sans ballonnet peut convenir dans certaines applications, et un mode de réalisation prévoit un ballonnet constitué d'élastomère conducteur qui sert en soi d'électrode.
PCT/US2000/041748 1999-11-01 2000-11-01 Tracheotrode et systeme d'electroventilation tracheale Ceased WO2001032249A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU26214/01A AU2621401A (en) 1999-11-01 2000-11-01 Tracheotrode and tracheal electroventilation system

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US16301199P 1999-11-01 1999-11-01
US60/163,011 1999-11-01
US70308400A 2000-10-31 2000-10-31
US09/703,084 2000-10-31

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Publication Number Publication Date
WO2001032249A1 true WO2001032249A1 (fr) 2001-05-10

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7594815B2 (en) 2003-09-24 2009-09-29 Toly Christopher C Laparoscopic and endoscopic trainer including a digital camera
US7665995B2 (en) 2000-10-23 2010-02-23 Toly Christopher C Medical training simulator including contact-less sensors
US7850454B2 (en) 2000-10-23 2010-12-14 Toly Christopher C Simulated anatomical structures incorporating an embedded image layer
US7857626B2 (en) 2000-10-23 2010-12-28 Toly Christopher C Medical physiological simulator including a conductive elastomer layer
WO2013184841A1 (fr) * 2012-06-05 2013-12-12 Texas Heart Institute Détermination d'emplacement de canule trachéale et procédés associés
US10037715B2 (en) 2013-10-16 2018-07-31 Simulab Corporation Detecting insertion of needle into simulated vessel using a conductive fluid
EP4019071A1 (fr) * 2020-12-23 2022-06-29 Biosense Webster (Israel) Ltd. Système de ventilation de patient doté de capteurs et d'électrodes couplés à un tube d'intubation
WO2024207289A1 (fr) * 2023-04-06 2024-10-10 Medtronic Xomed, LLC Système et procédé pour surveiller l'intégrité neuronale

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4827935A (en) * 1986-04-24 1989-05-09 Purdue Research Foundation Demand electroventilator
US4960133A (en) * 1988-11-21 1990-10-02 Brunswick Manufacturing Co., Inc. Esophageal electrode
US5024228A (en) * 1989-11-29 1991-06-18 Goldstone Andrew C Electrode endotracheal tube
US5125406A (en) * 1989-11-29 1992-06-30 Eet Limited Partnership (Del) Electrode endotracheal tube
US5584290A (en) * 1994-11-03 1996-12-17 Brain; Archibald I. J. Combined laryngeal mask airway and muscular or neuro-muscular response device
US5678535A (en) * 1995-04-21 1997-10-21 Dimarco; Anthony Fortunato Method and apparatus for electrical stimulation of the respiratory muscles to achieve artificial ventilation in a patient

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4827935A (en) * 1986-04-24 1989-05-09 Purdue Research Foundation Demand electroventilator
US4960133A (en) * 1988-11-21 1990-10-02 Brunswick Manufacturing Co., Inc. Esophageal electrode
US5024228A (en) * 1989-11-29 1991-06-18 Goldstone Andrew C Electrode endotracheal tube
US5125406A (en) * 1989-11-29 1992-06-30 Eet Limited Partnership (Del) Electrode endotracheal tube
US5584290A (en) * 1994-11-03 1996-12-17 Brain; Archibald I. J. Combined laryngeal mask airway and muscular or neuro-muscular response device
US5678535A (en) * 1995-04-21 1997-10-21 Dimarco; Anthony Fortunato Method and apparatus for electrical stimulation of the respiratory muscles to achieve artificial ventilation in a patient
US5911218A (en) * 1995-04-21 1999-06-15 Dimarco; Anthony Fortunato Method and apparatus for electrical stimulation of the respiratory muscles to achieve artificial ventilation in a patient

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7665995B2 (en) 2000-10-23 2010-02-23 Toly Christopher C Medical training simulator including contact-less sensors
US7850454B2 (en) 2000-10-23 2010-12-14 Toly Christopher C Simulated anatomical structures incorporating an embedded image layer
US7857626B2 (en) 2000-10-23 2010-12-28 Toly Christopher C Medical physiological simulator including a conductive elastomer layer
US8162668B2 (en) 2000-10-23 2012-04-24 Simulab Corporation Medical training simulator including contact-less sensors
US8323029B2 (en) 2000-10-23 2012-12-04 Toly Christopher C Medical physiological simulator including a conductive elastomer layer
US7594815B2 (en) 2003-09-24 2009-09-29 Toly Christopher C Laparoscopic and endoscopic trainer including a digital camera
WO2013184841A1 (fr) * 2012-06-05 2013-12-12 Texas Heart Institute Détermination d'emplacement de canule trachéale et procédés associés
US10058669B2 (en) 2012-06-05 2018-08-28 Texas Heart Institute Location determining endotracheal tube and methods
US10037715B2 (en) 2013-10-16 2018-07-31 Simulab Corporation Detecting insertion of needle into simulated vessel using a conductive fluid
EP4019071A1 (fr) * 2020-12-23 2022-06-29 Biosense Webster (Israel) Ltd. Système de ventilation de patient doté de capteurs et d'électrodes couplés à un tube d'intubation
US11642481B2 (en) 2020-12-23 2023-05-09 Biosense Webster (Israel) Ltd. Patient ventilation system having sensors and electrodes coupled to intubations tube
WO2024207289A1 (fr) * 2023-04-06 2024-10-10 Medtronic Xomed, LLC Système et procédé pour surveiller l'intégrité neuronale

Also Published As

Publication number Publication date
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